Therapeutic and protective dental device useful as an intra-oral delivery system

ABSTRACT

A dental device has a U-shaped carrier with at least one channel for embracing an arch of teeth. There are recessed insets in the channel. Discrete inserts carrying a beneficial agent can fit into the insets and release the agent gradually. The device may be used in a therapeutic application and as an athletic mouthguard. Temporary blanks may be initially fitted in the insets, while a portion of the mouthguard is softened before an arch of teeth is pressed into the channel to make a custom impression. The inserts possess different physical properties than the carrier and may be positioned and shaped to mechanically buffer teeth of the arch from mechanical shocks as well as release beneficial agents. The inserts may be replaced or refreshed to maintain the beneficial agent. A dental device having a core carrying a beneficial agent inside a liquid-permeable shell functions as an infant&#39;s teething device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.10/138,821, filed May 6, 2002, the entire disclosure of which is herebyincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to dental devices that are worn on an archof teeth, and in particular, to devices that can deliver a beneficialagent to, and protect the teeth and soft tissues from mechanical,chemical and biologic injury.

2. Description of Related Art

Mouthguards are typically made from plastics materials such as anethylene vinyl acetate copolymer (EVA). Other devices such asdentoalveolar trays, carriers and splints may be made of EVA or otherbiocompatible plastic material. There are several categories ofmouthguards: Mouthguards that are stock pre-molded products and made ina variety of sizes, home or self-moldable to suit the physicalcharacteristics of the user, or custom molded by a dentist or otherprofessional to suit the characteristics of the user. Regarding physicalprotection, stock mouthguards are typically the cheapest and leasteffective in use while the custom molded and shaped mouthguards are themost expensive and effective in their impact absorbent properties.

Athletes in many sports wear mouthguards for prolonged periods. It iscommon knowledge that when these athletes engage in strenuous physicalactivity, they lose and must replace significant amounts of fluids,nutrients and calories. In order to hydrate themselves, and replenishtheir energy, athletes must drink large quantities of fluids and eatfoods that are very often cariogenic. These cariogenic fluids andmaterials cover the teeth, and when a mouthguard is inserted afterwards,the teeth are acted upon by cariogenic bacteria in an ideal environment,shielded from the buffering ability of saliva. In athletes, factors thatserve to diminish salivary flow around the teeth include the generalsympathetic tone of the nervous system, dehydration and shielding of theteeth by a mouthguard. Moreover, the elderly, patients suffering from avariety of autoimmune diseases, patients on a variety of medications andpatients treated in the head region with external beam radiation mayalso suffer from reduced salivary flow. Whatever the cause, reducedsalivary flow greatly increases the incidence of dental caries andperiodontal disease.

U.S. Pat. No. 4,920,984 relates to a mouthguard material that may becustom shaped or molded employing a teeth impression cast pressedagainst softened thermoplastic sheet material that increases inthickness from one end to the other.

Australian patent specification 633269 discloses a mouthguard made froman EVA copolymer having a softening point higher than the normaltemperature of an oral cavity but lower than the highest temperaturethat the oral cavity can endure so that the user may adapt themouthguard to fit the mouth by biting onto it after it has been heated.The shaping procedure may be repeated if the shape or configuration ofthe teeth should change.

In FIG. 15 of U.S. Pat. No. 5,082,007 a gel or fluid capsule iscontained between the upper and lower portions of a mouthguard. Thenature of this gel is not described and appears to serve a mechanical,that is, a shock absorbing function.

It is not only known to employ materials enabling custom or self shapingof mouthguards, it has been suggested that mouthguards use otheradditives in the material of construction to enhance the characteristicsof the material. For example, in U.S. Pat. No. 4,044,762 an athleticmouthguard is formed from a mixture of a plastic resin (e.g., anethylene vinyl acetate that can be heated and softened to form acustom-fitted impression) and a fluoride compound that protects thewearer's teeth. As an alternative, the reference suggests spraying orotherwise coating the surface of a mouthguard with a fluoride compound.This fluoride compound is gradually delivered while the mouthguard isworn.

In FIGS. 7 and 8 of U.S. Pat. No. 5,323,787 a medicated pad isadhesively secured on the occlusal surface of a mouthpiece to treat theteeth and gums. The pad is saturated with a medicating substance in anintermediate layer of absorbent polymeric or fabric material, and thatintermediate layer is overlaid with a non-porous outer layer. The padcan either be replaced or soaked to renew the medication. Specificmedications are not discussed, although for other embodiments themouthpiece is soaked in sterilizing (bactericides) and mouth-refreshingingredients such as flavorings of the type used in conventionalmouthwashes.

German patent specification 401 1204 discloses a mouthguard materialconsisting of an EVA copolymer material, polycaprolactone and colorantsand perfumes and PVA (polyvinyl acetate) to reduce the softening pointof the resultant mouthguard for ease of manipulation and shaping.

In U.S. Pat. No. 5,395,392 an infant's pacifier has a perforated mouthbulb containing an powder, syrup, or tablet with an agent such asmonoclonal antibodies, fluorides, sorbitol, or xylite (xylitol).

Xylitol is a naturally occurring sugar. It is a five-carbon polyalcohol,pentitol, which is widely distributed in nature. Most fruits, berriesand plants contain xylitol. Xylitol is also an intermediate of mammaliancarbohydrate metabolism. Our bodies produce up to 1 5 grams of xylitolfrom other food sources using established energy pathways. Xylitol useis known to reduce tooth decay rates both in high-risk groups (highcaries prevalence, poor nutrition, and poor oral hygiene) and in lowrisk groups (low caries incidence using all current preventionrecommendations). Sugar-free chewing gums and candies made with xylitolas the principal sweetener have already received official endorsementsfrom numerous international dental associations. Studies using xylitolas either a sugar substitute or a small dietary addition havedemonstrated a dramatic reduction in new tooth decay, along with arrestand even some reversal of existing dental caries. Xylitol providesadditional protection that enhances all existing prevention methods.This xylitol effect is long lasting and possibly permanent. Low decayrates persist even years after the trials have been completed.

For the anticariogenic activity of casein phosphopeptides, see U.S. Pat.Nos. 5,015,628; 5,834,427 (method of preparing casein phosphopeptides);and 5,981,475. For various remineralizing compositions, see U.S. Pat.Nos. 4,348,381; 5,562,895; 5,895,641; and 6,036,944.

For various mouthguards and similar dental devices, see U.S. Pat. Nos.4,554,154 (plastic that is chewable or usable as dental floss carriesremineralizing, immunological, and anti-bacterial agents; e.g. sodiumfluoride, chlorhexidine and lysozyme); 5,085,585 (U-shaped applicator isplaced over teeth to apply medicaments to teeth and gum pockets);5,194,003 (device that fits over teeth releases beneficial agents from areservoir); 5,339,832 (composite mouthguard with integralshock-absorbing framework); 5,365,624 (mouthpieces with cleaning motorsor gum cushioning material); and 6,012,919 (occlusal protector pad in anathlete's dental appliance has an upper layer of EVA andpolycaprolactone).

Certain hydrogels, particularly synthetic hydrogels, can act as carriersfor drugs and other active agents. These hydrogels allow passage of theagent, in some cases acting as a membrane that allows agent passage.Covalently crosslinked hydrogels can incorporate a drug or other agentduring the polymerization step; or the agent can be loaded from asolution. These types of hydrogels tend, however, to be weak whenswollen by its water content. With thermoplastic (solvent soluble)hydrogels, an agent or drug can be compounded with the polymer duringextrusion or injection molding; or by combining the agent with thepolymer solution in a suitable solvent. See “Hypan® Hydrogels” publishedby Hymedix International, Inc. The Hypan® hydrogels can be obtained withvarying degrees of hydrophilicity. They can also be obtained either asrelatively hard, crystalline blocks, used for structural applications;or as meltable transient clusters that are highly swelling, and usefulas emulsifiers, gelling agents, and drug carriers. Various othersuppliers of hydrogel exist as well.

For hydrogels with improved stability, see U.S. Pat. No. 5,346,935. Seealso U.S. Pat. Nos. 5,071,657 (transdermal administration of a medicinalagent dissolved in a nonflowable gel distributed in a microdisperse modein a crosslinked silicone elastomer); 5,200,194 (oral osmotic device hasa beneficial agent and hydrophilic support fibers inside asemi-permeable membrane); and 5,252,692 (hydrophilic acryliccopolymers).

See also, U.S. Pat. Nos. 3,996,934 (bandage using microcapsules todeliver a drug); 5,366,935; 5,286,490 (transdermal patch deliversfluoride medication to treat osteoporosis or periodontal disease); and5,925,372 (transdermal delivery system for ethanol soluble drugs).

Thus, while prior art devices are capable of delivering an agent tosurfaces within the oral cavity, they lack the ability to deliver agentsto selected surfaces within the oral cavity, or to deliver one or moreagents to different oral surfaces simultaneously. The present inventionfulfills this long-felt need by being able to selectively deliver agentsto specific oral surfaces, and to be able to deliver multiple agents todifferent surfaces using a single device, which device includes numerousinsets for receiving agent-containing inserts therein. This agentdelivery function can be performed either independently of, or inconjunction with, the protective functions of the present invention,which can also act as an athletic mouthguard. Further, the presentinvention provides a means to recharge the device with an agent oncethat agent has been depleted.

SUMMARY OF THE INVENTION

In accordance with the illustrative embodiments demonstrating featuresand advantages of the present invention, there is provided a dentaldevice having a U-shaped carrier with at least one channel for embracingan arch of teeth. The carrier has at least one recessed inset in the atleast one channel. The dental device also has at least one discreteinsert carrying a beneficial agent. This insert is adapted to fit intothe inset and release the agent gradually.

In accordance with another aspect of the invention, the foregoing dentaldevice also includes at least one blank removably fitted into the atleast one inset.

In accordance with yet another aspect of the invention, a dental devicehas a U-shaped carrier with at least one channel for embracing an archof teeth. The carrier has at least one recessed inset in the at leastone channel. Also included is at least one discrete insert adapted tofit into the inset. The insert has a different physical character (e.g.,softer) than the carrier and is positioned and shaped to mechanicallybuffer teeth of the arch from mechanical shocks.

In accordance with still yet another aspect of the invention, a dentaldevice that can mechanically buffer an arch of teeth from mechanicalshocks has a U-shaped carrier with at least one channel for embracingthe arch of teeth. Also included is a beneficial agent suffused throughat least a portion of the carrier. The beneficial agent includes xylitolor sorbitol in one case, or a remineralizing agent in another case.

In accordance with a further aspect of the invention, a method isprovided that employs at least one insert and a U-shaped carrier havingat least one channel with at least one recessed inset containing ablank. The method includes the step of softening at least a portion ofthe carrier along the channel. Another step is pressing an arch of teethinto the channel to make an impression. The method also includes thestep of removing the blank from the at least one inset. Also included isthe step of installing the at least one insert into the at least oneinset.

In accordance with yet a further aspect of the invention, a methodemploys (1) a plurality of inserts suffused with a beneficial agent and(2) a U shaped carrier having at least one channel with a plurality ofrecessed insets. The method includes the step of installing selectedones of the inserts into less than all of the insets to from a firstinstalled insert pattern. Another step is removing at least some of theinserts from the carrier. The method also includes the step ofinstalling at least one of the inserts to form a second installed insertpattern. Thus, different oral regions can be affected by differentinsert patterns.

In accordance with still yet a further aspect of the invention, a methodemploys a beneficial agent and an athletic mouthguard. The methodincludes the step of suffusing the beneficial agent into the mouthguard.Another step is wearing the mouthguard in an athletic event.

In accordance with still yet a further aspect of the invention, there isprovided a kit for preparing a dental device. The kit includes a dentaldevice with at least one channel for embracing an arch of teeth. Thedental device has a carrier with at least one recessed inset in the atleast one channel. Also included is at least one discrete insert adaptedto carry a beneficial agent. The insert is adapted to fit into the insetand release the agent gradually. Also included is at least onebeneficial agent for incorporation into the at least one discreteinsert.

In accordance with still yet a further aspect of the invention, there isprovided a dental device having a core inside a liquid-permeable shell.The shell has a shape suitable for chewing or teething. The core carriesa beneficial agent and is adapted to release the agent gradually.

Methods and devices in accordance with the foregoing can chemically andphysically protect a person's teeth and gingiva. An oral device(“mouth-guard/carrier”) or method of the foregoing type can directlyapply agents to the teeth and, in one embodiment, provide for themechanical protection of the teeth from trauma as a mouthguard. Thismouthguard/carrier preferably contains individual undercut insetsadjacent to each tooth or groups of teeth into which will be placedtherapeutic agents contained in, for example, a hydrogel vehicle asdescribed hereinafter. The number of insets per tooth may vary, rangingfrom one to three (or more) to accommodate the lingual/palatal, buccaland occlusal surfaces. The agent included in a preferred embodiment isthe naturally occurring sugar, xylitol, although other beneficial agentsare contemplated as well; for example, remineralizing agents,moisturizing agents, desensitizing agents, flavoring agents, breathfresheners, chemical and biological indicators, nutraceuticals,antibiotics, probiotics, other medications and chemotherapeutics, etc.

Two generalized embodiments are described. In one embodiment, the deviceprovides an intra-oral device that serves as an athletic mouthguard,provides a novel means of enhanced shock absorption, and contains insetsfor agent-containing inserts to be described hereinafter. In someembodiments disposable inserts, containing agents to be describedpresently, are constructed primarily of hydrogels. The inserts areplaced into the device and release the intended agents directly onto thesurface of the teeth and/or gingiva. The novel shock absorptioncharacteristics of the device result from the unique mechanicalforce-distributive and dissipating properties of the (e.g., hydrogel)inserts that are placed in the anterior region (generally from canine tocanine) which serves an additional function of providing a noveladditive cushioning property against mechanical trauma.

In another embodiment, the steps include providing an intra-oral carriermade out of standard and typical dental appliance materials intendedsolely as a vehicle with insets for holding inserts that contain activeagents to be described, and for positioning these proximate to thedentoalveolar tissues. The carrier in this other embodiment is notnecessarily intended to provide mechanical protection for the teeth asin the other embodiment.

Thus the present specification discloses an intra oral device that mayor may not have mechanically protective features (i.e. function as amouthguard, depending on embodiment), may be applied to the maxillary ormandibular arch and will serve to deliver intra-orally, chemicals,therapeutics, medications, pharmaceuticals, nutraceuticals, etc. coveredby this application; specifically xylitol and other agents disclosedherein as exemplar applications of the agent delivery features of thepresent invention.

In one embodiment, the carrier material, made of orally acceptableplastics material, has one or more insets arranged to maximizemechanical protection of the teeth and surface contact to facilitateagent delivery. To maintain the shape and retentive integrity of theinsets, preferably, blanks will fill the insets and will require removalin order to insert the hydrogel inserts. These blanks will beparticularly useful in a “boil and bite,” self-molding carrier ormouthguard.

It is an object of one embodiment of the present invention to providethe ability to directly apply, in a timely fashion, agents to preventand/or reverse the decalcification of teeth, that is potentiated by theuse of a mouthguard, some transient physiologic states, as well as somemedical conditions and/or procedures or medications of a person.

It is a further object of the invention to provide an improved material(preferably, hydrogel inserts) that in conjunction with typical EVAmouthguard materials, or the like, provides enhanced impact absorbentproperties.

BRIEF DESCRIPTION OF THE DRAWINGS

The above brief description as well as other objects, features andadvantages of the present invention will be more fully appreciated byreference to the following detailed description of presently preferredbut nonetheless illustrative embodiments in accordance with the presentinvention when taken in conjunction with the accompanying drawings,wherein:

FIG. 1 is a plan view of a dental device showing the open channel of aU-shaped carrier;

FIG. 2 is a plan view showing the reverse side of the dental device ofFIG. 1;

FIG. 3 is a detailed, cross-sectional view of a blank fitted into anundercut inset of the dental device of FIG. 1;

FIG. 4 is a detailed, cross-sectional view of an insert replacing theblank of FIG. 3;

FIG. 5 is a detailed, cross-sectional view of an insert that is analternate to that of FIG. 4;

FIGS. 6A-6D are front views of dental arches showing in phantom fourdifferent arrangements of inserts for devices of the type shown in FIG.1;

FIGS. 7A-7E are a cross-sectional views of the device of FIG. 1 showinga sequence of steps performed when using that device;

FIG. 8 is a perspective view of dental device that is an alternative tothat of FIGS. 1-7 and is useful as a teething device for an infant; and

FIG. 9 is a cross-sectional view of the device of FIG. 9.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1 and 2, a dental device is shown as a U-shapedcarrier 10. Carrier 10 has a channel 12 serving as a recess forreceiving an arch of teeth A. In this embodiment the device has only asingle channel 12 for receiving the arch of teeth A, but otherembodiments may have channels on opposite sides for receiving two archesof teeth. The inside wall 12A and outside wall 126 of channel arereferred to as a lingual/palatal surface and buccal/labial surface,respectively. An occlusal/incisal surface 12C is located betweensurfaces 1 2A and 12B. Surfaces 1 2A-1 2C are collectively referred toas surfaces 12.

A central insert 1 4A is fitted into an inset in surface 1 2B, in frontof four incisors I and two canines C of arch A (this combination beingreferred to as the anterior six teeth). A pair of back inserts 14B arealso fitted into an inset in surface 1 2B, each in front of a pair ofpremolars P. Another pair of back inserts 1 4C are fitted into an insetin surface 1 2B, each in front of a pair of molars M (or in some casesall molars). Inserts 14A-14C are collectively referred to as inserts 14.These inserts 14 are placed symmetrically on the buccal surfaces.

The anterior insert 14A extends from canine to canine and laps theincisal edge and extends at least to the cervical junction. The twoposterior inserts 146 and 14C are adjacent to the second premolarthrough the second molar teeth, extending at least to the cervicalmargins. This insert pattern is intended to act as mouthguard-carrier,but other patterns are contemplated, especially for embodiments that areprimarily therapeutic.

As explained further hereinafter, a greater or lesser number of insertsmay be employed, and these inserts can be designed to cover a greater orlesser number of teeth. Also, this dental device may be initiallyshipped without inserts, in which case plastic blanks will be initiallyinstalled in the insets normally containing inserts 14.

Preferably, and as described further hereinafter, hydrogel inserts willbe emplaced within the buccal/labial wall 1 2B of the EVA plastic ofcarrier 10.

The intended material for carrier 10 may, for various embodiments, beany such material as is currently used in therapeutic dental carriers orsports mouthguards. Mouthguards are typically made from plasticsmaterials such as an ethylene vinyl acetate copolymer (EVA). Additivesmay be added to the EVA itself to provide special properties for themouthguard material. For example, a copolymer of ethylene and about 20%by weight vinyl acetate may be employed. In some embodiments of thisdevice, flavoring and aromatic agents may be added to the polymer.Colorants, perfumes and softening agents may also be added as well.

There are generally three categories: (1) Mouthguards that are stockpre-molded products and made in a variety of sizes. (2) Home orself-moldable to suit the physical characteristics of the user. (3)Custom molded by a dentist or other professional to suit thecharacteristics of the user.

Typically, custom-made mouthguards are fabricated by a vacuum-forming orpressure-forming process whereby two or three laminar sheets of EVA areheat adapted to a mold. The number of lamina used and the thickness atany point will be determined by the intended use of themouthguard/carrier, i.e. for therapeutics delivery only; or for deliveryof therapeutics while worn as a protective mouthguard in sports relatedactivities.

The illustrated embodiment is the self-moldable type. Accordingly, theocclusal/incisal surfaces 12C of the carrier 10 contain a chemicallybonded low-temperature plastic layer 10A that deforms on heating to thetemperature of boiling water (approximately 100 degrees Celsius). Theuser then “bites” into the channel 12 of device 10 and causes thelow-temperature plastic component 10A to mold and conform to the user'sdentoalveolar structures. The portion of the device 10 containing theinsets intended to bear the hydrogel inserts 14A-14C is not permanentlydeformable. (Note relatively stiff blanks may be placed in the insets inthe outer wall surface 12B of the EVA mouthguard/carrier 10 when animpression is made.)

In some embodiments, the carrier need not have separate inserts fittedinto recessed insets, since the carrier itself can deliver a beneficialagent. The polymer may contain agents, such as xylitol. In someembodiments the polymer may contain a remineralizing agent for restoringcalcium in teeth. Several flavors and/or aromas may be available toprovide a wide selection to the user. The purpose of this beneficialagent and additives is to: (1) Provide an incentive for use of the mouthguard. (2) Alert the user when other beneficial agents are exhausted.

In some embodiments of the present invention, the carrier is notintended to provide mechanical protection as a mouthguard, but isintended solely as an agent delivery system and may be fabricated fromorally acceptable plastics material and having multiple insets. Inembodiments intended for primarily therapeutic application of activeagents, there will be insets not only on the buccal/labial surface 1213,but on the lingual/palatal surface 12A as well (up to 32 for 16 teethper arch, buccal and lingual surfaces). In any event the insets canreceive hydrogel inserts for applying agents to the tissues in thisvicinity.

Referring to FIG. 3, during the manufacturing of the carrier 10, theshape and integrity of insets 15 are maintained by insert-shaped blanks18 comprising the same material as the carrier 10. The blanks 18 wouldremain in place during any “boil and bite” type of customizing moldingof stock mouthguard/carriers. The blanks 18 would be removed just priorto placement of the hydrogel inserts (see FIG. 4).

In the therapeutic carrier only embodiment, the blanks 18 may be left inplace for certain sites where no therapy is intended. In this carrierembodiment, individualized insets 15 may be adjacent to each tooth ortooth region on the buccal and lingual surfaces for a maximum of 64insets.

Referring to FIG. 4, the innermost portion of previously mentionedsurface 12, which is adjacent to the teeth and dentoalveolar tissues,will preferably hold preformed standard shaped inserts 14, formed ofhydrogel vehicles suffused with intended beneficial agents. The walls ofthe insets 15 will be undercut to provide for a mechanical “snap-in”lock of the hydrogel material. Insert 14 is shown having a beveled edge20 to accomplish this snap-in feature.

Referring to FIG. 5, carrier 10 is shown fitted with an alternate insert114. A matrix 122 embedded within insert 114 is in the form of a plasticmesh that enhances the rigidity and structural integrity of insert 114.Matrix 122 is shown spaced from the outer surfaces of inserts 114, butin some embodiments the mesh may be a porous covering encapsulating thehydrogel carrying the beneficial agent.

Referring to FIG. 6A, an upper arch A of teeth is shown overlaid inphantom with a carrier 110 similar to previously mentioned carrier 10.The teeth of arch A are marked as before. Again, center insert 14A isshown covering four incisors I and the canines C. In this embodiment,back insert 1481 has been lengthened from that of FIG. 2 to cover twopremolars P and three molars M. This pattern and the pattern of FIG. 2would be most appropriate for embodiments acting as a mouthguard thatmechanically buffers teeth from mechanical shocks, although nothingwould prevent these embodiments being used primarily for therapeuticpurposes.

The cervical region of the teeth is that region where the teeth narrowdown, or form a neck. This is normally found around cervical line N. Inany event, the cervical region, as that term is used herein, is notintended to define a mathematically precise domain, but a region in theneighborhood of cervical line N. Directions extending away from thecervical region N across the crown of the teeth and toward the distalend of the teeth are indicated by direction arrow 16 and are referred toas a occlusal and incisal direction (or extending occlusally andincisally).

In this embodiment, the purpose of the device is twofold, i.e. to serveas a shock-absorbing mouthguard and therapeutic carrier. There are 3 (insome cases 5) insets in the buccal/labial wall of the mouthguard/carrier110 into which is placed agent-containing hydrogels 14A and 14131. Thehydrogels serve a second role of shock absorption and cushioning inorder to protect the teeth from damaging physical contact.

Referring to the embodiment of FIG. 6B, the purpose of the device isalso twofold, i.e. to serve as a mouthguard, but primarily as atherapeutic carrier. There exist approximately 30 insets in thebuccal/labial and lingual/palatal walls of the mouthguard/carrier intowhich are placed agent-containing inserts 14′ made of hydrogels. Theinserts 14′ on opposite sides of the teeth will typically (but notnecessarily) be in registry. The hydrogels will serve a second role ofshock absorption and cushioning in order to protect the teeth fromdamaging physical contact, however, the primary role is to deliveragents to the teeth. The inserts 14′ are each positioned to span acrossa pair of adjacent teeth. For strictly therapeutic purposes, not all ofthe inserts 14′ will be installed but will be placed in a patternappropriate for those teeth needing treatment.

Referring to the embodiment of FIG. 6C, the purpose of the device 10″ isas a therapeutic carrier to bring active agents to the periodontium,cervical areas and/or interproximal areas of the teeth. There exist one(up to three) insets located at the cervical margins N of the teeth onthe buccal and lingual walls of the carrier 10″ into which is placedagent-containing, hydrogel inserts 14″.

Referring to the embodiment of FIG. 6D, the purpose of the device 10′″is as a therapeutic carrier to bring active agents to the periodontium,cervical areas and/or interproximal areas of the teeth. There existapproximately 30 insets in the buccal/labial and lingual/palatal wallsof the mouthguard/carrier into which are placed agent-containinghydrogels 14′″.

Referring to FIG. 7A, a cross-sectional view is given ofmouthguard/carrier 10, through a location intended for a centralincisor. The mouthguard 10 is in this embodiment a generic “stock”shape, composed of standard mouthguard material such as an ethylenevinyl acetate copolymer (EVA) substitute or equivalent.

In addition, there is an EVA blank 18 in the mouthguard/carrier's inset15 intended to maintain the integrity of shape of the inset during a“boil and bite” heating process, to resist deformation. The boil andbite feature is provided herein by the moldable layer 1 OA′ formed onsurface 1 2A of carrier 10. Layer 10A′ is chemically bonded to the EVAas a separate, low-temperature material attached to surfaces apart fromthe inset and strategically placed to conform to the dentoalveolarprocess and teeth of the user when the material is heated and the user“bites” into the mouthguard/carrier.

As shown in FIG. 7B, a user now “bites” into device 10 to make animpression on moldable layer 10A′. Significantly, blank 18 provides afirm surface for teeth such as incisor I, so that a reliable impressioncan be made.

Referring to FIG. 7C, after the molding process, the EVA blank 18 isremoved, but moldable layer 10A′ maintains an impression of the teeth.As shown in FIG. 7D, blank 18 will be replaced at an appropriate timewith the agent-containing hydrogel insert 14.

Referring to FIG. 7E, in use, the hydrogel 14 is in contact with thelabial surface of the incisor I, as well as other teeth. The hydrogel 14releases, over time and in appropriate quantities, the active agent. Inaddition, the hydrogel's mechanical properties enhance theshock-absorbing properties of the carrier 10 as a mouthguard.

For embodiments having as their main purpose preventing and/or reversingcariogenic activity, inserts 14 will apply agents such as xylitoldirectly to the teeth. This beneficial agent allows the use of device 10as a mouthguard, which would otherwise act to accelerate decalcificationby shielding the teeth from the natural cleansing activity of the lips,cheeks and tongue and buffering action of the saliva. In addition, thevehicle intended to bring the active agents to the teeth (hydrogels 14)have unique physical properties that would be adjunctive in thedissipation of potentially harmful kinetic energy directed at the teeth.is that the hydrogel acts as a diffusion barrier that allows the agentsto be released over a period of hours. Efficacious drug levels areachieved near the device surfaces, but the agents dilute out quicklyinto body fluids as they move away from the device. Only extremely lowsystemic levels of the agents result because of the dilution.

The preferred vehicle for agent delivery is a commercially availablehydrogel, such as Hypan° hydrogel from Hymedix International, Inc.,Dayton, N.J. This hydrogel is reported to be a hydrophilic acrylatederivative, with each polymer chain having several sequences of unitswith pendant hydrophilic groups (called soft blocks) and severalsequences of pendant nitrile groups (referred to as hard blocks). Thelengths of the blocks, and/or the nature of the side groups, as well asthe overall hydrophilicity of the polymer, are varied depending uponproduction conditions.

Other hydrogels and agent-releasing vehicles from various sources andsuppliers are contemplated for other embodiments. The preferred vehicleswill be able to contain, and slowly release at a biocompatible rate andconcentration, chemicals known to promote dental health and enamel anddentinal recalcification, such as: (1) Complex of calcium casein peptonederived from milk (CPP) and amorphous calcium phosphate (ACP), orCPP-ACP. (2) Xylitol. (3) Fluoride containing compounds, such as: (a)Sodium Fluoride; (b) Stannous Fluoride.

Other hydrogel materials which are contemplated by the present inventioninclude compounds such as polyhydroxy ethyl methacrylate, chemically orphysically crosslinked polyacrylamide, polyvinyl alcohols, poly(N-vinylpyrolidone), polyethylene oxide, and hydrolyzed polyacrylonitrile.Polysaccharide-based hydrogels, such as covalent or chemicallycrosslinked polyvalent metal salts of alginates, pectines,carboxymethylcellulose, heparin and hyaluronic acid, as well ashydrogels containing chitin, chitosan, gellan, pullulan, and xanthan arealso contemplated by the present invention.

Other fluoride containing compounds that may be suitable for use withthe present invention include inorganic fluoride salts such as solublealkali metals; alkaline earth metals; and heavy metal salts, forexample, potassium fluoride, ammonium fluoride; cuprous fluoride; zincfluoride; stannic fluoride; barium fluoride; sodium fluorosilicate;ammonium fluorosilicate; sodium fluorozirconate; aluminum mono- anddifluorophosphate, fluorinated sodium calcium pyrophosphate and sodiummonofluorophosphate. Calcium fluoride; cobalt ammonium fluoride; zincammonium fluoride; and stannous ammonium fluoride can also be used. Thenknown amine fluorides are also suitable organic fluorides which arecontemplated by the present invention.

Also, the remineralizing or recalcifying agents envisioned herein may bevarious calcium salts such as calcium phosphate. A commerciallyavailable remineralizing agent is sold as Recaldent””, although otherremineralizing agents are contemplated. Other agents such as fluoridecontaining chemicals (e.g. stannous fluoride, sodium fluoride), xylitolmay be used in combination. The chemical will be activated by saliva andreleased from the hydrogel material at a rate that will be non-toxic.

Examples of remineralizing agents include calcium compounds such as:amorphous calcium phosphate; amorphous calcium phosphate fluoride;amorphous calcium carbonate phosphate fluoride, amorphous calciumcarbonate phosphate; potassium oxalate. Other compounds from whichcalcium ions may be obtained include calcium chlorides; calcium nitrate;calcium acetate; calcium benzoate; calcium butyrate; calcium gluconate;calcium formate; calcium fumarate; calcium glycerophophoshate; calciumlactate; calcium isobutyrate; calcium malate; calcium maleate; calciumproprionate and calcium valerate, and mixtures thereof.

Source of inorganic phosphorus for use in a remineralizing compositioninclude mono- and dibasic calcium phosphate; dipotassium phosphate;monosodium phosphate; sodium metaphosphate; and alkali salts andammonium salts of orthophosphoric acid, such as sodium, potassium orammonium orthophosphate.

A water soluble salt, such as monobasic calcium orthophosphate, can alsobe used, as a source of both calcium and phosphate ions for use as aremineralizing agent.

The preferred vehicles will also be able to contain and graduallyrelease agents suitable for treating periodontal disease, such aschlorhexidine, or various antibiotics. Chlorhexidine is most commonlyused in the digluconate form, although other chlorhexidine containingcompounds can be employed. Tetracycline, doxycycline, oxytetracycline,chloramphenicol, penicillin, amoxicillin, erythromycin, streptomycin,sulfonamides, aminoglycosides, cephalosporins, quinolones are among theantibiotics which can be employed in the present invention. Neomycin,kanamycin, amikacin, tobramycin and gentamycin are among theaminoglycoside antibiotics which can be used. Additional compounds caninclude antiviral agents, such as acyclovir or zidovudine; or antifungalagents, such as imidazoles or polyene antibiotics. Antibacterial agentssuch as benzethonium chloride, benzalkonium chloride, cetylpyridiniumchloride, or dequalinium chloride are also contemplated. The preferredvehicles will also be able to appropriately deliver intraoraldeodorants; and agents for improving the aesthetic appearance of teeth(whiteners), e.g., peroxide containing and peroxide generatingcompounds. It is also desirable to use a device that can flavor thecarrier and therapeutic elements so as to provide an incentive to usethe mouth guard, and alert the user that the protective elements areexhausted and may need to be replaced or recharged.

The present invention contemplates inclusion of sweeteners andflavorings known to those skilled in the art. These agents can beselected from among those in the following list, which is intended forexamples only, and not intended as any limitation:

Sugar alcohols such as xylitol, sorbitol, mannitol, and mixturesthereof;

Water-soluble sweeteners, including monosaccharides, disaccharides andpolysaccharides, such as xylose, ribose, glucose, mannose, galactose,fructose, sucrose, maltose, glycerine and partially hydrolyzed starch orcorn syrup;

Artificial sweeteners such as aspartyl-phenylalanine methyl ester,acesulfame K, saccharin and sodium cyclamates.

As stated above, xylitol is a preferred sweetener because of its knownnon-cariogenic actions; sorbitol may also be substituted therefor.

The flavorings contemplated by the present invention include bothnatural and artificial flavors, and mint flavors such as spearmint andpeppermint. Flavors such as wintergreen, anise and cinnamon are alsoincluded. Fruit flavors, including citrus flavors like orange, lemon andtangerine and other flavors, either individually or in blends thereof,are also included. These flavorings are generally utilized inconcentrations that depend upon the individual flavor, and may range,for example only, in concentrations of approximately 0.05% toapproximately 6% by weight of the final composition.

In addition, colorants may added to the compositions. Among thecolorants are pigments which may comprise up to about 2% by weight ofthe composition. These colorants can include what are known to thoseskilled in the art as “FD & C” and “D&C” dyes, meaning dyes suitable foruse in food, drug and cosmetic applications. It is preferred that thedyes utilized be watersoluble. Some examples include a triphenylmethanedye, FD&C Green #3, or a yellow dye designated D&C Yellow #10. TheKirk-Othmer Encyclopedia of Chemical Technology, 3^(rd) edition, volume6, pages 361-495 contains a comprehensive listing of FD&C colorantswhich may be useful in conjunction with the present invention, includingtheir chemical structures, and whose contents are hereby incorporated byreference herein.

In an embodiment of this device intended to serve as a mouthguard also,the hydrogel insert will be an integral component of the mouthguard andprovide a mechanical barrier/cushion contributing to the cushioning andenergy dissipative properties of the mouth guard. The hydrogel will havesufficient integrity of form to maintain its overall shape and tomechanically lock into the receptacle in the mouthguard. The integrityof form may be an intrinsic property of the hydrogel or may result froman encasement or framework that provides the necessary integrity ofshape, yet allows an adequate diffusion of agent from the hydrogel.Indeed, the encasement may be desirable in order to control the rate ofdiffusion of the active agent.

In any event, following the instructions for use, the device and thehydrogel vehicle will deliver preferably not more than 15 grams ofxylitol per 24 hours. At this rate of drug delivery, xylitol is fairlysafe.

It is appreciated that various modifications may be implemented withrespect to the above described, preferred embodiment. For example, thepresent invention may be distributed in the form of a kit, containingthe dental device, one or more inserts, and a quantity of at least onebeneficial agent which can then be incorporated into the insert of thedental device.

Referring to FIGS. 8 and 9, the illustrated dental device 20 functionsas an infant's teething device, although chewing by adult users arecontemplated for some embodiments. While this device is shown as a ringor toroid, in other embodiments it may be shaped as a disk, a rod, orhave various other shapes. In some embodiments the teething device mayhave a handle. In this embodiment the illustrated teething ring 20 has atoroidal core 22 made of a hydrogel as described above or a similarsubstance.

Core 22 may be contained inside a liquid-permeable shell, shown in thisembodiment as a plastic skin 24 that is perforated by a multiplicity oforifices 26. These orifices may be arranged with a density of 10 to1,000 orifices per square inch (1.6 to 160 orifices per squarecentimeter), although other embodiments may have a different densitydepending upon the desired permeability, skin strength, etc. Thethickness of the skin 24 will vary with the strength of the skin'splastic material, balanced against the weakening effect of the orifices26. The skin should be thick enough to avoid rupture, but thin enough toallow adequate diffusion of the active agents contained in the hydrogelcore 22. For example, with a skin made of an EVA polymer, a skinthickness of 0.5 mm to 2.0 mm will operate satisfactorily, although inother embodiments the thickness may be outside this range. Furthermore,the distribution of orifices need not be uniform and may be more denselyspaced in regions where the infant's gums or teeth engage the skin 24.The orifices 26 may be formed with a roller (not shown) having a largenumber of small piercing pins. The sheet of plastic skin, beforeinstallation, may pass over this roller, or the roller may be rolledover the plastic skin.

The skin 24 may be formed from an upper half 24A and a lower half 24Bjoined along an outer seam 26 and an inner seam 28. These seams may bewelded by heat sealing, by gluing, or by other fastening means. Also,some embodiments may have just an inner seam 28, in which case the skin24 will be one continuous piece with only one seam. Alternatively, theskin can be formed from more than two pieces. In some embodiments, theskin may be formed by spiral wrapping the skin around the toroidalshape. Instill other embodiments, the skin may be molded in place eitheras a perforated surface or a continuous surface that is laterperforated.

Core 22 is encased in an optional scrim 30, which will be a porousmatrix such as a knit or woven fabric. Alternatively, scrim 30 may be afibrous matrix that is readily penetrated by liquid, or a relativelyimpermeable sheet that is perforated by a number of holes to act as apermeable matrix.

In use, the infant may chew on the teething ring 20 in the usualfashion. The core 22 will be deformed and the active agent containedtherein will tend to diffuse through the orifices 26. The core 22 can besuffused or impregnated with any one of the beneficial agents mentionedabove, or any combination thereof. Also, in the instance of an infant'steething device, the beneficial agents may include substancesappropriate for soothing the infant's gums. Such agents may be numbingagents or analgesics typically used to soothe the gums.

Obviously, many modifications and variations of the present inventionare possible in light of the above teachings. It is therefore to beunderstood that within the scope of the appended claims, the inventionmay be practiced otherwise than as specifically described.

1-25. (canceled)
 26. An insert for a dental device, the dental deviceincluding a carrier having at least one channel adapted to receive atleast a portion of an arch of teeth therein when the carrier is worn bya user, the carrier including at least one recessed inset defined by aninner surface extending into the carrier, the inset having an open endalong a surface of the carrier, the insert comprising: a body discretefrom the carrier having a predefined shape complementary to a shape ofthe inset such that the body is adapted to be detachably received withinthe inset in a received position in which an outer surface of the bodyis substantially contiguous with the inner surface of the inset.
 27. Theinsert of claim 26, wherein, when the body is in the received positionand the carrier is worn by the user, the body extends along the carrierso as to span a plurality of teeth of the arch and the body has anexposed surface along the open end of the inset, the exposed surfacebeing substantially flush with the surface of the carrier adjacent tothe inset.
 28. The insert of claim 27, wherein the outer surface of thebody is shaped to interact with the inner surface of the inset so as toform a snap-in lock that holds the body in the received position. 29.The insert of claim 28, wherein the body has a beveled edge shaped toengage an undercut of the inset so as to form the snap-in lock.
 30. Theinsert of claim 27, wherein the body comprises pullulan.
 31. The insertof claim 27, wherein the body is formed of a material having abeneficial agent suffused therethrough.
 32. The insert of claim 26,wherein, when the body is in the received position and the carrier isworn by the user, the body extends along the carrier so as to span aplurality of teeth of the arch, and wherein the outer surface of thebody is shaped to interact with the inner surface of the inset so as toform a snap-in lock that holds the body in the received position. 33.The insert of claim 32, wherein the body has a beveled edge shaped toengage an undercut of the inset so as to form the snap-in lock.
 34. Theinsert of claim 32, wherein the body comprises pullulan.
 35. The insertof claim 32, wherein the body is formed of a material having abeneficial agent suffused therethrough.
 36. The insert of claim 26,wherein the body is formed of a material having a beneficial agentsuffused therethrough, the body being shaped to interact with the innersurface of the inset so as to form a snap-in lock that holds the body inthe received position.
 37. The insert of claim 36, wherein the body hasa beveled edge shaped to engage an undercut of the inset so as to formthe snap-in lock.
 38. The insert of claim 36, wherein the body comprisespullulan.
 39. The insert of claim 36, wherein, when the body is in thereceived position, the body has an exposed surface along the open end ofthe inset, the exposed surface being substantially flush with thesurface of the carrier adjacent to the inset.
 40. A dental device,comprising: the insert of claim 26; and the carrier; wherein the channelof the carrier is bound by a buccal/labial wall, a lingual/palatal wall,and an occlusal/incisal wall therebetween, and wherein the inset of thecarrier is located within either the buccal/labial wall or thelingual/palatal wall.
 41. An insert for a dental device, the dentaldevice including a carrier having at least one channel adapted toreceive at least a portion of an arch of teeth therein when the carrieris worn by a user, the carrier including at least one recessed insethaving an open end at a surface of the carrier, the insert comprising: abody discrete from the carrier, the body of the insert being adapted tobe detachably received within the inset in a received position, whereinthe body is shaped to interact with the inset so as to form a snap-inlock that holds the body in the received position.
 42. The insert ofclaim 41, wherein, when the body is in the received position and thecarrier is worn by the user, the body extends along the carrier so as tospan a plurality of teeth of the arch.
 43. The insert of claim 41,wherein the body of the insert is formed of a material having abeneficial agent suffused therethrough.
 44. The insert of claim 41,wherein the body has a beveled edge shaped to engage an undercut of theinset so as to form the snap-in lock.
 45. The insert of claim 41,wherein, when the body is in the received position, the body has anexposed surface along the open end of the inset, the exposed surfacebeing substantially flush with the surface of the carrier adjacent tothe inset.
 46. The insert of claim 41, wherein the body comprisespullulan.
 47. A dental device, comprising: the insert of claim 41; andthe carrier; wherein the channel of the carrier is bound by abuccal/labial wall, a lingual/palatal wall, and an occlusal/incisal walltherebetween, and wherein the inset of the carrier is located withineither the buccal/labial wall or the lingual/palatal wall.
 48. A dentaldevice, comprising: a carrier having at least one channel adapted toreceive at least a portion of an arch of teeth therein when the carrieris worn by a user, the carrier including at least one recessed insethaving an open end along a surface of the carrier; and at least oneinsert having a body discrete from the carrier, the body of the insertbeing adapted to be detachably received within the inset in a receivedposition, wherein, when the body is in the received position, the bodyhas an exposed surface along the open end of the inset, the exposedsurface being substantially flush with the surface of the carrieradjacent to the inset.
 49. The dental device of claim 48, wherein, whenthe body of the insert is in the received position and the carrier isworn by the user, the body and the inset extend along the carrier so asto span a plurality of teeth of the arch.
 50. The dental device of claim48, wherein the carrier is U-shaped so as to receive substantially theentire arch of teeth when the carrier is worn by the user.